Policy
An unnamed FDA official also told reporters that it would be good for Moderna to “show some humility” and admit that it didn’t follow the regulator’s recommendations in testing its mRNA flu vaccine.
FEATURED STORIES
Bristol Myers Squibb, GSK and Merck are contributing drug ingredients as part of their deals with the White House but are keeping many of the terms of their agreements private.
Some 200 rare disease therapies are at risk of losing eligibility for a pediatric priority review voucher, a recent analysis by the Rare Disease Company Coalition shows. That could mean $4 billion in missed revenue for already cash-strapped biotechs.
The FDA’s rare pediatric disease priority review voucher program missed reauthorization at the last minute in 2024; advocates have been fighting to get it back ever since.
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Bridge Therapeutics Inc. announced that it has received feedback from the Food and Drug Administration from a Pre-Investigational New Drug meeting for the development of BT-219, a therapy to treat Opioid Dependence.
Reston Hospital Center Nationally Recognized With An ‘A’ Hospital Safety Grade by The Leapfrog Group
Reston Hospital Center was awarded an ‘A’ Leapfrog Hospital Safety Grade for fall 2019, a national distinction recognizing Reston’s achievements in protecting patients from harm and providing safer health care..
Polarean Imaging plc, the medical-imaging technology company, with a proprietary magnetic resonance imaging (MRI) drug-device combination, announces that the enrolment for its Phase III non-inferiority clinical trials (the “Clinical Trials”) is now complete for both the lung transplant pathway and the lung resection pathway.
The approval marks the first approved treatment in the United States for this condition.
The legal challenges of diversity in the workplace is an issue that every human resources professional needs to take control of to ensure optimal inclusion.
Houston, TX Fannin Innovation Studio announces its receipt of a $2,000,000 Phase II Small Business Innovation Research grant from the National Institute of Health Eunice Kennedy Shriver National Institute of Child Health & Human Development for development of its ChorioAnchor device, in partnership with Texas Children’s Hospital, Baylor College of Medicine, and Texas A&M University
HHS stated that Gilead had “willfully and deliberately induced infringement of the HHS patents.” As a result, “Gilead has profited from research funded by hundreds of millions of taxpayer dollars and reaped billions from PrEP,” through the sale of Truvada and Descovy.
The division previously had three clinical divisions and one nonclinical division. Under the restructuring, it will six divisions, three for oncology.
Artios Pharma Limited, The University of Texas MD Anderson Cancer Center and ShangPharma Innovation announce the in-licensing by Artios of a small-molecule ATR inhibitor programme, developed jointly by MD Anderson and ShangPharma.
Reaffirms Biocon’s Capability to Manufacture Biosimilars for Patients in U.S.